Sexual Arousal DisorderNCT06445855
The Effectiveness of Online Interpersonal Relationships-Based Pyschoeducation in Increasing Sexual Interest and Arousal in Women With Sexual Interest and Arousal Disorder
A study testing Interpersonal relationship-based intervention program in people with Sexual Arousal Disorder and Sexual Desire Disorder, run by Marmara University.
Trial summary
This study will be conducted to examine the effectiveness of interpersonal relationships-based online psychoeducation developed for women with sexual interest and arousal disorders. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Arousal Disorder, Sexual Desire Disorder
- What is being tested?
- Interpersonal relationship-based intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A person of female biological sex,
- Expressing difficulties in sexual interest and arousal (yes to at least three of the following criteria) (questions related to these criteria will be added to the interview form)
- Decrease/absence in frequency or intensity of sexual activity,
- Decrease/absence of sexual fantasies/erotic thoughts,
- Inability to initiate sexual intercourse with their partner,
- Lack of sexual excitement and pleasure in almost all sexual relationships (about 75%),
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- Decreased/absence of sexual interest/arousal to internal or external sexual erotic stimuli (e.g. written, oral, visual),
- Decreased/absence of genital or nongenital sensations in almost all sexual relationships (approximately 75%).
- Low mean scores on the Female Sexual Function Index and Sexual Interest and Desire Inventory-Female scales (mean score on the Female Sexual Function Index below 26.55, mean score on the Sexual Interest and Desire Inventory-Female below 33)
- Have sufficient knowledge about the use of the Internet,
- Women who have had a sexual partner for at least 1 year are among the inclusion criteria for this study.
Who cannot join
- Becoming pregnant or planning pregnancy during the psychoeducation period,
- Receive treatment for any sexual dysfunction,
- Withdrew from the study at any stage of the study,
- Women who do not attend more than one session of the psychoeducation will not be included in the study (Women who miss the weekly program of the psychoeducation will be allowed a maximum of 2 make-up sessions).
About this study
This study will be conducted to examine the effectiveness of interpersonal relationships-based online psychoeducation developed for women with sexual interest and arousal disorders.
Read the detailed description
Female sexual interest and arousal disorders are common among sexual dysfunctions. In addition to the physical and mental health of women with sexual interest and arousal disorder, interpersonal relationships are also negatively affected. Based on this relationship, it is predicted that interpersonal relationship-based psychoeducation will be effective in the treatment of sexual interest and arousal disorder.
Interpersonal Relationship Psychotherapy or counseling is a short-term, easy, accessible approach that focuses specifically on interpersonal problems and is based on attachment theory, aiming to reduce depressive symptoms and improve interpersonal functioning.
The number of internet users and the possibilities of access to the internet are increasing significantly all over the world, and online health services via the internet are becoming widespread. Online psychoeducation inevitably takes its place in internet-based applications with technological developments.
In this context, this study will be conducted to increase the sexual interest and arousal levels of women with sexual interest and arousal disorders through online psychoeducation.
- Conditions
- Sexual Arousal Disorder, Sexual Desire Disorder
- Being tested
- Interpersonal relationship-based intervention program
- Keywords
- Sexual Arousal Disorder, Sexual Desire Disorder, Online Intervention Program, Sexual Interest/ Arousal Disorder
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal relationship-based intervention programBehavioural
An interpersonal relations-based intervention program will be implemented with an online intervention platform.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Women in the experimental group will receive an 8-week online intervention program based on interpersonal relationships. An internet-based intervention application will be developed for this intervention. All interventions will be implemented from this intervention. Receives: Behavioral: Interpersonal relationship-based intervention program |
| Waiting group | Other | After the interventions in the experimental group are completed, the intervention program will be applied to the women in the waiting group. Receives: Behavioral: Interpersonal relationship-based intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Interest and Desire Inventory-Female (SIDI-F)
The inventory is a 13-item inventory developed to measure the level of sexual interest and arousal of women specifically in the last 4 weeks. A total score between 0 and 51 is obtained from the SIDI-F. The cut-off score of the inventory is 33 and 94.7% of the women below this score have a sexual interest and desire disorder.
Measured: 12 weeks
Secondary outcomes (4)
Female Sexual Distress Scale-Revised
The 13-item scale, which was developed to evaluate the distress experienced by women with sexual dysfunction, has a 5-point Likert structure. The increase in the scale score indicates an increase in the level of sexual distress in women. The cut-off score of the scale is 11.
Measured: 12 weeks
Female Sexual Function Index (FSFI)
The scale was developed to evaluate the sexual problems and sexual functions of individuals in general in the last 4 weeks and consists of 19 questions and 6 subcategories (sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain). The first 2 questions of the scale are related to "sexual desire", questions 3-6 to "sexual arousal", questions 7-10 to "lubrication", questions 11-13 to "orgasm", questions 14-16 to "satisfaction" and questions 17-19 to "pain" subcategories. Questions 1, 2, 15 and 16 are scored between 1 and 5, while the remaining items are scored between 0 and 5. The highest score that can be obtained from the scale is 36 and the lowest score is 2.
Measured: 12 weeks
Interpersonal Relationship Dimensions Scale
the dimensions of interpersonal relationships. It has four sub-dimensions: dependency, empathy, trust in others and emotional awareness. The higher the score, the higher the related sub-dimension
Measured: 12 weeks
System Usability Scale (SUS-TR)
hardware, mobile devices, online web pages. It is a five-point Likert-type scale with 10 items. Items with odd numbers are scored from one to five, while items with even numbers are scored from five to one. In the scale score calculation, the score obtained from each participant is multiplied by 2.5 and a score between 0-100 is obtained. A high score on the scale indicates that the usability of the system is high.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start30 Sep 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Arousal DisorderStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One waiting group and one experimental group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Dilşah Yılmaz, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445855
- Sponsor's protocol ID
- Istanbul University-Cerrahpasa
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Online Interpersonal Relationships-Based Pyschoeducation in Increasing Sexual Interest and Arousal in Women With Sexual Interest and Arousal Disorder
- ClinicalTrials.gov ID
- NCT06445855
- Acronym / sponsor ID
- Istanbul University-Cerrahpasa
- Conditions
- Sexual Arousal Disorder, Sexual Desire Disorder
- Keywords
- Sexual Arousal Disorder, Sexual Desire Disorder, Online Intervention Program, Sexual Interest/ Arousal Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to examine the effectiveness of interpersonal relationships-based online psychoeducation developed for women with sexual interest and arousal disorders.
Detailed description
Female sexual interest and arousal disorders are common among sexual dysfunctions. In addition to the physical and mental health of women with sexual interest and arousal disorder, interpersonal relationships are also negatively affected. Based on this relationship, it is predicted that interpersonal relationship-based psychoeducation will be effective in the treatment of sexual interest and arousal disorder.
Interpersonal Relationship Psychotherapy or counseling is a short-term, easy, accessible approach that focuses specifically on interpersonal problems and is based on attachment theory, aiming to reduce depressive symptoms and improve interpersonal functioning.
The number of internet users and the possibilities of access to the internet are increasing significantly all over the world, and online health services via the internet are becoming widespread. Online psychoeducation inevitably takes its place in internet-based applications with technological developments.
In this context, this study will be conducted to increase the sexual interest and arousal levels of women with sexual interest and arousal disorders through online psychoeducation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- One waiting group and one experimental group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Interpersonal relationship-based intervention programWomen in the experimental group will receive an 8-week online intervention program based on interpersonal relationships. An internet-based intervention application will be developed for this intervention. All interventions will be implemented from this intervention. |
| Waiting group | Other | Behavioral: Interpersonal relationship-based intervention programAfter the interventions in the experimental group are completed, the intervention program will be applied to the women in the waiting group. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- A person of female biological sex,
- Expressing difficulties in sexual interest and arousal (yes to at least three of the following criteria) (questions related to these criteria will be added to the interview form)
- Decrease/absence in frequency or intensity of sexual activity,
- Decrease/absence of sexual fantasies/erotic thoughts,
- Inability to initiate sexual intercourse with their partner,
Key exclusion criteria (4 listed)
- Becoming pregnant or planning pregnancy during the psychoeducation period,
- Receive treatment for any sexual dysfunction,
- Withdrew from the study at any stage of the study,
- Women who do not attend more than one session of the psychoeducation will not be included in the study (Women who miss the weekly program of the psychoeducation will be allowed a maximum of 2 make-up sessions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal relationship-based intervention programAn interpersonal relations-based intervention program will be implemented with an online intervention platform. | Behavioural | Experimental group, Waiting group |
Primary outcome
Sexual Interest and Desire Inventory-Female (SIDI-F)
Time frame: 12 weeks
The inventory is a 13-item inventory developed to measure the level of sexual interest and arousal of women specifically in the last 4 weeks. A total score between 0 and 51 is obtained from the SIDI-F. The cut-off score of the inventory is 33 and 94.7% of the women below this score have a sexual interest and desire disorder.
4 secondary outcomes
Female Sexual Distress Scale-Revised
Time frame: 12 weeks
Female Sexual Function Index (FSFI)
Time frame: 12 weeks
Interpersonal Relationship Dimensions Scale
Time frame: 12 weeks
System Usability Scale (SUS-TR)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- website addressLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal relationship-based intervention program in people with Sexual Arousal Disorder and Sexual Desire Disorder, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Interest and Desire Inventory-Female (SIDI-F) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.